Extractables And Leachables: Setting Up Early For Success With Your CDMO

Explore a wealth of information specifically designed for drug product researchers and manufacturers, offering in-depth insights into extractables, leachables, and effective implementation strategies. This session will cover critical topics, including industry standards, regulatory expectations, and best practices for ensuring the success of your drug development programs.

Key areas of focus will include:

• Extractables and Leachables: Gain a comprehensive understanding of the importance of identifying and mitigating extractables and leachables in drug products, ensuring product safety and compliance.
• Regulatory Intelligence: Stay up-to-date with the latest regulatory feedback, particularly from the FDA, and learn from real-world program successes to enhance your own development processes.
• Keys to Success: Dive into practical advice on essential factors such as optimal timing, strategic planning, selecting the right partners, and crafting a clear roadmap for your projects.
• Simulated Leachable Studies: Learn the differences between real-time and simulated leachable studies, along with their respective benefits, to ensure robust data generation and risk assessment.

This session will provide actionable guidance on how to navigate the complexities of extractables and leachables in drug development, with a focus on aligning with regulatory expectations and achieving successful outcomes.